(136 days)
Not Found
No
The device description focuses on the material properties and mechanical design of a bioresorbable pin for toe surgery. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies.
No.
The device is a small hammer toe pin used for arthrodesis, which is a surgical procedure to fuse a joint. While it is used in a medical context, it is an implantable device used for structural support and joint fusion, rather than directly applying therapy. Therapeutic devices typically involve active treatment, diagnosis, or prevention of disease, often through energy, substances, or biological processes. This device is a passive implant.
No
The device is a medical implant (pin) used for arthrodesis, which is a surgical procedure to fuse a joint. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical pin made of bioresorbable material, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ProToe™ EndoSorb™ Small Hammer Toe Pin Function: This device is an implantable pin used for surgical fixation of a joint within the body (in vivo). It is a surgical device, not a diagnostic test.
The description clearly states its use in a surgical procedure for joint fusion, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDW
Device Description
The ProToe™ EndoSorb™ Small Hammer Toe Pin is made out of the bioresorbable EndoSorb™ material and is indicated for proximal interphalangeal (PIP) joint arthrodesis. EndoSorb™ is a polyerster derivative of L-Lactic and glycolic acids. Poly(L-lactide-co-glycolide) material (PLGA) degrades and resorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the body. The device has threads on one side and barbs on the other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal (PIP) joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Submission Date: 09.02.2010
| 2 510(k) Summary | |
|---|---|
| Submitted by: | Merete Medical GmbH |
| Alt Lankwitz 102 | |
| 12247 Berlin, Germany | |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Emmanuel Anapliotis |
| Merete Medical, Inc. | |
| 49 Purchase Street | |
| Rye, New York 10580 | |
| Phone: 914 967 1532 | |
| Proprietary Name: | ProToe™ EndoSorb™ Small Hammer Toe Pin |
| Common Name: | Arthrodesis Pin |
| Device Classification: | Screw, Fixation, Bone, Non-spinal, non-metallic |
| (888.3040) | |
| Product Code: | HWC |
Proposed Regulatory Class: Class II
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Small Hammer Toe Pin, Biomet, Inc. (K021828); Resorbable Hammertoe Pin, Biomet. Inc. (K011137)
Intended Use:
The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Device Description:
The ProToe™ EndoSorb™ Small Hammer Toe Pin is made out of the bioresorbable EndoSorb™ material and is indicated for proximal interphalangeal (PIP) joint arthrodesis. EndoSorb™ is a polyerster derivative of L-Lactic and glycolic acids. Poly(L-lactide-co-glycolide) material (PLGA) degrades and resorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the body. The device has threads on one side and barbs on the other.
91
1
510(k) Submission - ProToe™ EndoSorb™ Small Hammer Toe Pin
Substantial Equivalence:
The ProToe™ EndoSorb™ Small Hammer Toe Pin is similar to legally marketed predicate device listed above in that it shares similar indications for use, is manufactured from similar materials and incorporate similar technological characteristics. Any differences have been found to have no obvious effect on the performance, function, or intended use of the prosthesis.
Software Documentation:
No software is needed for the use of this device.
92
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Merete Medical GmbH % Merete Medical, Inc. Mr. Emmanuel Anapliotis 49 Purchase Street Rye, New York 10580
JUL.-2 2010
Re: K100414
Trade/Device Name: ProToe™ EndoSorb™ Small Hammer Toe Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW, HWC Dated: June 25, 2010 Received: June 28, 2010
Dear Mr. Anapliotis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Emmanuel Anapliotis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Buehrig
Mark N. Me son Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
p. '1/1
Submission Date: 09.02.2010
Indications for Use Statement 1
Indications for Use
510(k) Number (if known):
Device Name: ProToe™ EndoSorb™ Small Hammer Toe Pin
Indications for Use:
The ProToe™ EndoSorb™ Small Hammer Toe Pln is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Merete Medical GmbH · Alt Lankwitz 102 · 12247 Berlin, Germany · Phone: +49 (0)30 / 77 99 80-0 US Agent: Merete Medical, Inc. • 49 Purchase Street • Rye, N.Y. 10580 • Phone: 914 • 067-1552
3